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Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only.
The conventional therapies for HZ infection can be seen in two phases. Those in acute phase are mainly antiviral (acyclovir, famciclovir, etc.), analgesic drugs (opioids, acetaminophen or nonsteroidal anti-inflammatory agents, gabapentin, etc.), while these conventional drug therapies could yield potential side effects, and part of patients are not fully satisfied with the analgesic effect. It is considered that supplementary and alternative local therapies may have better results with less side effects and reduce medical costs to relieve pain associated with HZ infection. These options, including nerve blockade (epidural injection, paravertebral injection, sympathetic block, intercostal nerve block, intracutaneous injection), pulsed radiofrequency16, acupuncture, fire needling acupuncture, electrical nerve stimulation19, lidocaine patch, capsaicin cream, and botulinum toxin injection have been reported to give positive therapeutic effects on acute herpes zoster neuralgia (AHN), however, evidence for the efficacy of existing local therapies is limited and risks may occur due to high invasiveness of some procedures, there is insufficient evidence and expert agreement to make recommendations for these intervention strategies as first-line treatments in guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard gorup | Active Comparator | Patients will receive standard oral medicine for herpes zoster. |
|
| TPI group | Experimental | Patients will receive standard medicine treatment and tender point infiltrations therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| analgesic | Drug | Patients will receive daily 300 mg pregabalin in divided doses (150 mg/12 hours). Once the patient report mild pain (VAS ≤ 3), the trial for reducing the pregabalin dose will be done. Nonsteroidal anti-inflammatory drug celecoxib (200 mg on request, up to two times daily)27 and tramadol (100 mg on request, up to 400mg daily) will be available for as-needed analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of postherpetic neuralgia using VAS score | 12 months after the treatments, number of patients with any pain with a VAS score of higher than 0/Number of all patients,0="no pain" and 10="worst pain imaginable" | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale score at each time point | 0 = 'no pain at all' to 10 = 'worst pain imaginable' | before the treatment (baseline), 30min after the intervention (for TPI group), then 1 day, 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment |
| Proportion of patients receiving repeated TPIs and block points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang Luo, M.D. | Beijing Tiantan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
|
| Tender point infiltration | Behavioral | Lidocaine mixed with diprospan injected into tender points. |
|
|
Number of patients receiving TPI treatments more than twice/Number of all patients |
| 12 months |
| Consumption of oral drugs at each time point | Dose of celecoxib, pregabalin and tramadol | day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment. |
| The presence of PHN at month 3 and month 6 post treatment | Number of patients with any pain with a VAS score of higher than 0/Number of all patients (0 = 'no pain at all' to 10 = 'worst pain imaginable') | 3 and 6 months after treatments |
| Patient satisfaction scores on the 5-point Likert scale | 1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied | day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment |
| Quality of life on the Scores on the WHOQOL-BREF | Scores on the WHOQOL-BREF. The responses are given on 5-point Likert scale (1-5) and the overall score ranges from 0 to 100; a higher score corresponds to better QoL. | day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment |
| Adverse reactions through study completion | Any side effect and uncomfortable situation related to treatment through study completion,an average of 1 year | After treatments |
| Predictive factors for the prevention of PHN at month 12 posttreatment | the correlation between patients' baseline characteristics and the incidence of PHN will be analyzed 12 months after treatment in TPI group. | month 12 posttreatment |
| D007239 | Infections |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |